RecruitingPhase 2NCT05132504

Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer

Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Pembrolizumab Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas

Sponsor

Baylor College of Medicine

Enrollment

30 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma

Summary

Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the immunotherapy drug pembrolizumab to standard chemotherapy (FOLFIRINOX) before surgery can improve outcomes for patients with pancreatic cancer that can potentially be surgically removed. **You may be eligible if...** - You are 18 or older - You have been diagnosed with pancreatic adenocarcinoma that is localized and potentially removable by surgery - Your cancer does not involve major blood vessels (SMA, hepatic artery) in a way that prevents surgery - You have adequate organ function **You may NOT be eligible if...** - You have a neuroendocrine tumor of the pancreas - Your cancer has spread too far to be surgically removed - You have already received treatment for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab will be initiated starting with the Cycle 2 Day 1 and will be administered every 6 weeks with a max amount of 9 cycles throughout the study.

DRUGFolfirinox

Once eligibility has been confirmed and the patient has been registered to the study, the patient will begin induction modified FOLFIRINOX (Oxaliplatin, Leucovorin, Irinotecan, 5-Fluorouracil) chemotherapy treatment. Each cycle is 14 days; a total of six cycles will be administered. Patients will receive growth factor support at the discretion of treating physician.